RegulatoryGuideline · final

FDA finalises guidance on testing blood donations to reduce transfusion-transmitted hepatitis B risk

🇺🇸 FDA · Tue 03 Nov 2026

The final guidance sets out FDA's recommendations for HBV testing of Whole Blood and blood components, including Source Plasma, and replaces several older memoranda.

The US Food and Drug Administration has announced the availability of a final guidance, "Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus". The notice appeared in the Federal Register on 3 November 2026 (91 FR 69258, Docket No. FDA-2024-D-5942).

The document is addressed to blood establishments that collect blood and blood components, including Source Plasma. It gives the agency's recommendations on testing for hepatitis B virus (HBV), with the stated aim of lowering the risk of HBV being transmitted through transfusion. The recommendations apply to collection of Whole Blood and blood components, Source Plasma included.

The guidance finalises the draft "Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen", which FDA announced in July 2025. It also supersedes a number of earlier documents, among them the December 1987 memorandum on managing donors and units that are initially reactive for hepatitis B surface antigen (HBsAg) and the September 1991 memorandum on testing for antibody to hepatitis B core antigen (anti-HBc). The summary supplied also lists a further superseded document on adequate and appropriate donor screening tests for hepatitis B, but its title is cut off, so the full list of replaced documents should be checked in the official notice.

The Federal Register entry also contains sections on background, the Paperwork Reduction Act of 1995 and electronic access. The text available does not set out the detailed technical recommendations, so establishments will need to consult the guidance itself. As context, FDA guidance documents describe the agency's current thinking and are not legally binding unless specific regulatory requirements are cited.

What it means for your team

  • Blood establishments and Source Plasma collectors should read the final guidance against their current HBV testing and donor-management procedures.
  • Quality teams should check which legacy practices were based on the 1987 and 1991 memoranda, which the new guidance supersedes.
  • Anyone who commented on the July 2025 draft should compare the final text with it to see what changed.
  • Verify the full list of superseded documents in the official Federal Register notice, as the summary on file is truncated.

Official guideline text: FDA ↗

Article written by VigiEye from the official source (FDA). AI-assisted; check the source before acting.

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